NCT06016829

Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 121 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment.

Detailed description

A questionnaire form containing general information, dietary habits, and food consumption records will be applied by the researcher in the preoperative period to the patients who volunteered to participate in the study. Body composition will be taken by bioelectrical impedance analysis method. Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of patients will be assessed using the criteria of the Nutritional Risk Screening 2002 (NRS-2002) and the Global Leadership Initiative on Malnutrition (GLIM). For body composition analysis, computed tomography images, known as the gold standard, will be used in cancer patients. Computed tomography images of the patients will be obtained from hospital records at L3 lumbar vertebra level. The software program ImageJ developed by the US National Institute of Health will be used to calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area (cm2) from the recorded images. Preoperative biochemical parameters will be obtained from hospital records. The systemic inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be calculated using the Dietary Inflammatory Index. The quality of life of patients will be assessed using cancer-specific scales developed by the European Organisation for Research and Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal cancer-specific quality of life.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Nutrition Risk Screening 2002 (NRS-2002)	Nutritional status assessment tool
DIAGNOSTIC_TEST	Global Leadership Initiative on Malnutrition (GLIM)	Nutritional status assessment tool
OTHER	Measurement of body composition with computed tomography (CT)	The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)
DIAGNOSTIC_TEST	Dietary inflammatory index (DII)	The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.
DIAGNOSTIC_TEST	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)	Quality of life assessment tool
DIAGNOSTIC_TEST	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)	Quality of life assessment tool
DIAGNOSTIC_TEST	Prognostic Nutritional Index (PNI)	Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
DIAGNOSTIC_TEST	Neutrophil-Lymphocyte Ratio (NLR)	The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.

Timeline

• Start date: 2021-07-25
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2023-08-30
• Last updated: 2024-02-28

Locations

2 sites across 1 country: Turkey (Türkiye)